Imugene (ASX:IMU) Wins FDA IND Approval to Kick Off PD1-Vaxx’s Phase 1 Trial in US

  • November 04, 2020 02:35 PM AEDT
  • Team Kalkine
Imugene (ASX:IMU) Wins FDA IND Approval to Kick Off PD1-Vaxx’s Phase 1 Trial in US

Summary

  • Imugene has received the US FDA IND approval to kick-start Phase 1 clinical trial of PD1-Vaxx in the US.
  • The FDA approval enables Imugene to commence patient dosing and recruitment in its Phase 1 clinical trial in the US in non-small cell lung cancer patients.
  • The Hackensack University Medical Center based in New Jersey is the first hospital to commence patient dosing in the US.
  • Currently, the PD1-Vaxx clinical trial is screening patients to enter into the clinic trial in Australia.
  • The Company has already obtained three HREC approvals to initiate the Phase 1 clinical study.
Gold MTF non-AMP

Imugene Limited (ASX:IMU) has achieved another significant milestone with the receipt of the US Food and Drug Administration (FDA) Investigational New Drug (IND) approval to kick-start Phase 1 clinical trial of PD1-Vaxx in the US.

PD1-Vaxx is Imugene’s B-Cell activating immunotherapy that has been designed to treat cancerous tumours in the lung, in the first instance. Lung Foundation Australia estimates over 12,500 Aussies are diagnosed with lung cancer annually.

The immuno-oncology company is in the process of initiating a multi-centre dose-escalation study of PD1-Vaxx (Phase 1 trial) both as a standalone therapy and in combination with immune checkpoint inhibitors like Keytruda® and Opdivo®. The Phase 1 trial of PD1-Vaxx is targeted to:

  • determine safety,
  • ascertain optimal biological dose as a monotherapy, and
  • measure efficacy and immune response.

Patient Dosing to Commence in US

The FDA approval enables Imugene to commence patient dosing and recruitment in its Phase 1 clinical trial in the US in non-small cell lung cancer patients.

The Hackensack University Medical Center based in New Jersey is the first hospital to commence patient dosing in the US. In September this year, Hackensack University Medical Center received Western Institutional Review Board approval to initiate Phase 1 human trial of PD1-Vaxx.

Imugene is planning to subsequently open additional clinical sites in the US at the Ohio State University Medical Center and Mayo Clinic in Phoenix, Arizona.

Patient Screening Undergoing in Australia

Imugene’s PD1-Vaxx clinical trial is currently screening patients to enter into the clinical trial in Australia. The Company has already obtained three Human Research Ethics Committee (HREC) approvals to initiate Phase 1 clinical study of its checkpoint immunotherapy candidate, PD1-Vaxx in Australia.

The three approvals have been provided to Sydney-based Chris O’Brien Lifehouse and Macquarie University, along with Melbourne-based Cabrini Hospital.

The approvals affirmed that the Company has completed all the essential pre-clinical safety and efficacy testing on PD1-Vaxx necessary to begin human trials. Besides, the approvals signify a major milestone for Imugene and clinicians treating patients suffering from lung cancer.

Imugene’s research indicates that PD1- Vaxx has the potential to stop lung cancer cells from preventing T-Cell recognition and successive killing, which then gives the T-Cells with the skill to identify cancerous cells and mount an immune system response.

Imugene’s work with PD1-Vaxx seems to be progressing well, and its footprint in the Company’s roster appears to be firmly in place and imprinted in its forward strategy.

Imugene shares traded at $0.058 during the early trade hours on 4 November 2020.

Interesting Read: Imugene (ASX:IMU) Makes Sizeable Progress in Product Pipeline in Q3 2020

 

 


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